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3. Child Physical Health and Trauma

Recommendation 3.1: Congress, HHS, and DHS/FEMA should ensure availability of and
access to pediatric medical countermeasures (MCM) at the Federal, State, and local levels
for chemical, biological, radiological, nuclear, and explosive threats.

Provide funding and grant guidance for the development, acquisition, and stockpiling
of MCM specifically for children for inclusion in the Strategic National Stockpile (SNS)
and all other federally funded caches, including those funded by DHS/FEMA.

Amend the Emergency Use Authorization to allow the FDA, at the direction of the HHS
Secretary, to authorize pediatric indications of MCM for emergency use before an
emergency is known or imminent.

Form a standing advisory body of Federal partners and external experts to advise the
HHS Secretary and provide expert consensus on issues pertaining specifically to
pediatric emergency MCM.

Within the HHS Biomedical Advanced Research and Development Authority, designate
a pediatric leader and establish a pediatric and obstetric working group to conduct gap
analyses and make research recommendations.

Include pediatric expertise on the HHS Enterprise Governance Board or its successor
and all relevant committees and working groups addressing issues pertaining to MCM.

Establish a partnership between the proposed MCM Development Leader and key
pediatric stakeholders both within and outside government.

Children are subject to higher levels of exposure and harm following chemical and biological incidents.95 Children inhale more air and consume more water on a per-weight basis than adults.96 Therefore, if a chemical, biological, radiological, nuclear, or explosive agent enters into the environment, children are more vulnerable than adults to the agent's adverse effects. Although these considerations should warrant greater attention to children during emergencies, the quantity of pediatric medical countermeasures (MCM)97 in the Strategic National Stockpile (SNS)98 is very limited. While the SNS maintains MCM for adults for high-threat agents, comparable pediatric indications and countermeasures for children are largely unavailable or have not been approved by the Food and Drug Administration (FDA).99 It is critical that the Federal Government take all steps necessary to remedy fully and quickly these gaps in coverage for children currently present within the SNS, in addition to ensuring that MCM developed and approved in the future have pediatric indications, dosages, and formulations.

A summary report of a February 2010 workshop sponsored by the Public Health Emergency
Medical Countermeasures Enterprise (PHEMCE)100 reemphasized the need for certain
populations, especially children, to have immediate access to MCM.101 The workshop report
discusses how incentives to develop pediatric MCM102 are impeded by the obstacles
involved in conducting clinical trials of MCM on children.103 Although procurement contracts issued by the Biomedical Advanced Research and Development Authority (BARDA) for chemical, biological, radiological, and nuclear threats contain options to extend label indications to pediatric populations, the incentive is unsuitable since the participation of children in controlled trials is virtually impossible.104,105

In December 2009, in the aftermath of the H1N1 pandemic, the Department of Health and
Human Services (HHS) Secretary directed the Office of the Assistant Secretary for
Preparedness and Response (ASPR) to lead a thorough review of its entire MCM system and
make recommendations.106 The Public Health Emergency Medical Countermeasures
Enterprise Review, released in August 2010, recognizes the need to enhance the
development and regulatory review of MCM for vulnerable populations, including children
and pregnant women, as part of a broader effort to improve MCM regulatory science,
domestic manufacturing capacity, coordination and collaboration, and financial
incentives.107 While the review does not specify in greater detail the significant gaps that
currently exist in our Nation's portfolio of MCM for children, the Commission supports
several of the recommendations in the review because they provide promising opportunities
to address the disparate challenges that are unique to children, through new mechanisms
and investments.

The review appropriately recommends that HHS identify a senior leader for the MCM
enterprise (MCM Development Leader). The Commission recommends that there be a
partnership between this leader and key pediatric stakeholders both within and outside
government. This partnership should include the Commission, but in addition, key nongovernmental organizations, such as the American Academy of Pediatrics. Furthermore, HHS reported to the Commission that it has identified research and development needs and
regulatory issues surrounding pediatric MCM, yet funding is not available to address these
gaps. This information should be coordinated with the MCM Development Leader and
shared with the BARDA senior leadership council.

The review proposes the creation of an independent strategic investment entity for MCM
innovation and development. Pediatric MCM should be a priority and therefore it is vital for
this entity to have pediatric expertise. The review also calls for a reassessment of how
liability protection is offered to the parties involved in MCM development, testing,
manufacturing and administration. The Commission concurs, as liability concerns are
perceived to be a significant barrier to pediatric labeling and the application of MCM to
children.

The review recommends that the FDA be resourced with enhanced capability and capacity
to work proactively with industry sponsors and researchers in targeted areas in the hope that
this activity might help to expedite the development of MCM. In addition, the Commission
recommends that one of the targeted regulatory science enhancement initiatives for the FDA
be pediatric labeling and formulations for existing MCM in the SNS.

The review refers to the FDA's role in the Emergency Use Authorization (EUA) process but
does not appear to acknowledge that the EUA (or a modified EUA mechanism) might be a
useful tool in creating more timely solutions to emerging or perceived threats-and
particularly so for children. Recognizing that the development of FDA-approved MCM for
children may take several years, the Commission recommends that Congress amend the
EUA statute to permit the FDA, at the direction of the HHS Secretary, to authorize pediatric
indications of MCM for emergency use before an emergency is known or imminent. The
Project BioShield Act of 2004108 established the EUA, which permits FDA to approve "the
emergency use of drugs, devices, and medical products (including diagnostics) that were
not previously approved, cleared, or licensed by FDA"and "the off-label use of approved
products in certain well-defined emergency situations."109,110 Despite this mechanism, FDA
lacks authority to authorize MCM prior to a declaration of an emergency, which prevents
the stockpiling of pediatric MCM in the SNS for ready availability, which places children at
an unacceptable risk. Pediatric indications should be authorized when sufficient data exist
regarding the pediatric dose and administration of the MCM, and when expert consensus
advises that it is prudent to stockpile the MCM for pediatric use during an emergency.

In its Interim Report, the Commission recommended that the HHS Secretary establish an
advisory committee of Federal and external partners to provide expert consensus opinion on
issues pertaining specifically to pediatric MCM.111 The advisory committee could review
existing data and information on MCM and provide rationale and consensus-based
recommendations for use with children during an emergency, ideally before an emergency
occurs. The 2006 Pandemic and All-Hazards Preparedness Act112 specifically gives the HHS
Secretary the authority to establish a working group of experts to "obtain advice regarding
supporting and facilitating advanced research and development related to qualified
countermeasures and qualified pandemic or epidemic products that are likely to be safe
and effective with respect to children, [etc.]." HHS suggested to the Commission that the
advisory committee be established as a standing committee within the NBSB, which has a
broad scope beyond children. The Commission believes this approach is insufficient and
urges Congress and the HHS Secretary to establish this advisory committee as a separate
entity solely dedicated to children.

Finally, the Commission recommends that ASPR designate a pediatric leader within BARDA,
supported by a pediatric and obstetric working group, to conduct gap analyses on MCM for
children and pregnant women, make research recommendations and provide input to
Federal procurement contracts for MCM. Also, as recommended in the Interim Report,
existing committees and working groups must include pediatric experts to ensure children
are represented when MCM are being prioritized for development and procurement.113 HHS reported that the PHEMCE includes pediatric subject matter experts on all of its interagency
activities, such as Requirements Working Groups and Integrated Program Teams. The
Commission acknowledges these positive actions and recommends that pediatric leadership
also be included on PHEMCE's Enterprise Governance Board, which is proposed to be
replaced by the Enterprise Senior Council (ESC). The ESC will include senior leaders of
PHEMCE "to oversee and serve as the decision forum for MCM development policy and
implementation."114 Appropriate pediatric leadership would ensure that pediatric MCM
needs are consistently considered throughout the entire MCM development process.

Recommendation 3.2: HHS and DoD should enhance the pediatric capabilities of their
disaster medical response teams through the integration of pediatric-specific training,
guidance, exercises, supplies, and personnel.

HHS should develop pediatric capabilities within each National Disaster Medical
System (NDMS) region.

NDMS has
responded to domestic and international emergencies and disasters, including Hurricane
Katrina and the 2010 earthquake in Haiti.

As highlighted in the Commission's Interim Report, NDMS' pediatric capabilities are limited,
even though children constitute a substantial percentage of DMAT patients.117 For example,
only two of the 53 DMATs are Pediatric Specialty Teams118 and less than 6 percent of NDMS
clinical practitioners have subspecialty training in pediatrics.119 Findings from the
Commission's April 2010 field visit to Florida to examine the domestic impact from the
Federal response to the Haiti earthquake highlighted the need to supplement DMATs with
pediatric specialty health care providers, expand NDMS' hospital network to include more
pediatric health care facilities, and improve Federal capability to transport pediatric patients.120

In its Interim Report, the Commission made specific recommendations for improving NDMS'
pediatric capabilities, including: adding core competencies on treatment and care of children
to NDMS national credentialing standards; providing pediatric education and training to all
DMAT members; equipping DMATs with appropriate pediatric supplies and equipment prior
to deployments; establishing protocols for delivering care; and developing new pediatric
"strike teams"for responding to disasters in which large numbers of children are injured.121

Developing a reserve pool of qualified professionals who have the credentials and
competence to provide a service, but cannot commit to "full-time"NDMS membership.122

Initiating a cache development program to define a cache standard for pediatrics.

Developing objectives and guidelines for a standard pediatric training curriculum for NDMS
response teams.123 The Commission recommends HHS develop a detailed plan for
accomplishing these objectives.

The Commission recommends that NDMS form a pre-credentialed reserve pool of pediatric
professionals to supplement DMATs. DMATs often do not have members with expertise in
key pediatric specialties, such as individuals who provide surgical, intensive care, nursing,
or neonatology services. Difficulty in recruiting pediatric health care providers to DMATs is
often due to the significant time commitment for travel, training, and exercises. As an
alternative to recruiting pediatric specialists as full-time DMAT members, a reserve pool of
pediatric specialists could provide individuals to supplement a DMAT if there is a high
demand during an emergency for their particular expertise. For example, many health care
workers, including more than 1,200 pediatricians and children's hospital personnel,124 spontaneously volunteered to work in Haiti after the 2010 earthquake. Despite their good
intentions, many of these professionals could not participate because they had not been
previously trained and credentialed by emergency response organizations. NDMS would
identify reserve pool members before a disaster to ensure they receive proper credentials,
liability coverage, and basic disaster training. NDMS is working with pediatric
organizations such as the National Association of Children's Hospitals and Related
Institutions and the American Academy of Pediatrics to encourage membership in DMATs
and reserve pools. The NDMS should assess the current state of its network and work with
stakeholder groups to further expand participation by pediatric centers. This would serve to
increase the available bed capacity—and particularly critical care beds—and awareness
and management of that limited resource.

The Commission also recommended that a Pediatric Health Care Coordinator be designated
on each federally funded medical response team,125 with responsibility for developing
strategies for enhancing pediatric medical expertise within the team. In response, the U.S.
Public Health Service's Office of Force Readiness and Deployment (OFRD), which oversees
U.S. Commission Corps teams126 that deploy in response to public health emergencies,
established Pediatric Health Care Coordinators.127 OFRD also committed to evaluating the
feasibility of expanding its Readiness and Response Program to include rostered Pediatric
Strike Teams within existing resources and funding. However, OFRD noted that funding is
not provided in the Fiscal Year (FY) 2011 budget request for OFRD pediatric teams or
pediatric-specific field training or exercises. The Commission recommends that Congress
appropriate funds to support these activities and that HHS include funds in the FY 2012
budget request. Furthermore, the Commission urges HHS and other Federal agencies,
particularly the Department of Defense (DoD), to establish and appropriately resource
Pediatric Health Care Coordinators on their medical response teams.

Recommendation 3.3: HHS should ensure that health professionals who may treat
children during a disaster have adequate pediatric disaster clinical training.

The President should direct the Federal Education and Training Interagency Group for
Public Health and Medical Disaster Preparedness and Response (FETIG) to prioritize
the development of pediatric core competencies, core curricula, training, and research.

The FETIG should support the formation of a Pediatric Disaster Clinical Education and
Training Working Group to establish core clinical competencies and a standard,
modular pediatric disaster health care education and training curriculum.

Health professionals, whether responding to a disaster scene or treating survivors in a hospital, must have appropriate training to provide needed medical care to children. Children are a significant portion of the population and are as likely as adults, if not more likely, to sustain serious injuries during disasters. In 2009 and 2010, Federal disaster response teams were deployed to disaster sites in American Samoa and Haiti, where children constitute approximately 40 percent of the population. In Haiti, children sustained serious crushing injuries, in many cases requiring amputations.128

Emergency managers and health professionals should plan and train for an anticipated number of pediatric survivors requiring medical care after a disaster based on the demographics of their community. Pediatric training provided to emergency medical responders varies in content and quality primarily due to the absence of national standards for pediatric disaster education and training.129 As noted previously, few DMAT members have formal subspecialty training in pediatrics.130 Also, the National Guard Bureau staff reported that there is very limited pediatric training for emergency responders who are not already pediatric specialists.131

The Commission recommends that the President direct the Federal Education and Training
Interagency Group for Public Health and Medical Disaster Preparedness and Response (FETIG)132 to address these deficiencies. As part of this effort, the Commission recommends that FETIG, working through the National Center for Disaster Medicine and Public Health
(NCDMPH), should prioritize the development of pediatric core competencies, core curricula, training, and research in the NCDMPH's work plan. The Commission recommends that all Federal agencies represented on the FETIG, particularly HHS as the coordinating agency for Emergency Support Function (ESF) #8,133 provide the resources necessary to support the mission and continuation of the FETIG.

To complete this work, the FETIG should support the formation of a Pediatric Disaster Clinical Education and Training Working Group with appropriate pediatric subject matter experts to complete this work. The Commission's Interim Report recommended forming this working group to: establish detailed core competencies and skill sets for different types of responders and health care professionals; develop a national training curriculum based on those core competencies; review existing training materials; provide guidance on how to incorporate children into exercises and drills; and build continuing education requirements into licensing and re-certification processes.134

The importance of training is reflected in the HHS 2009 National Health Security Strategy
(NHSS), which outlines actions for ensuring the Nation's health in the event of a major
disaster or incident. One of NHSS' 10 strategic objectives is to "develop and maintain the
workforce needed for national health security."135 The lack of training and certification
standards is noted as one obstacle to achieving this objective.136 A companion NHSS
Implementation Guide outlines specific activities to be accomplished in 2010, including
prioritizing areas of investment and developing workforce competencies.137 The
Commission recommends that HHS explicitly address the needs of children in its efforts to
expand workforce training and development.

Recommendation 3.4: The Executive Branch and Congress should provide resources for a
formal regionalized pediatric system of care to support pediatric surge capacity during
and after disasters.

HHS should include pediatric surge capacity as a "Required Funding Capability" in the
Hospital Preparedness Program.

States and hospital accrediting bodies should ensure all hospital emergency
departments stand ready to care for ill or injured children through the adoption of
emergency preparedness guidelines jointly developed by the American Academy of
Pediatrics, the American College of Emergency Physicians, and the Emergency Nurses
Association.138

A mass casualty event or major public health emergency involving children will rapidly overwhelm local health care response capabilities. Communities must develop pediatric medical surge plans that focus on incorporating and sharing local, regional, State, and Federal resources. Regionalization of emergency care was one of the key recommendations of the 2006 Institute of Medicine (IOM)'s Committee on the Future of Emergency Care.139 Formal regionalized pediatric systems have been associated with improvements in daily patient outcomes as well as medical surge capacity during disaster response and long-term recovery.140,141

In September 2009, Federal, State, and local policymakers and stakeholders assessed progress made since the IOM's 2006 report during a two-day workshop on regionalizing emergency care sponsored by the Emergency Care Coordination Center.142 Representatives from key Federal agencies offered comments on opportunities and challenges going forward, including the need for: data-driven approaches to measuring effectiveness and designing systems; a Congressional action plan for advancing regionalization; the establishment of roles, responsibilities, and priorities of a lead Federal agency; and consistency across all regional emergency medical services (EMS) systems.

In light of the ongoing challenges, the Commission recommends that the Executive Branch and Congress invest greater resources to assist health care systems in regionalization, compliance with the national emergency care guidelines for children, and development of pediatric medical surge capacity for disasters. The 2009 American Recovery and Reinvestment Act143 allocated funds for comparative effectiveness research, providing an opportunity to bolster research on regionalized systems of pediatric care. Additional funding for demonstration projects on regionalization was authorized in the 2010 Patient Protection and Affordable Care Act.144 The scope of this authorization includes at least four projects that will design, implement, and evaluate innovative regional emergency medical care systems. An explicit requirement is that all grantees address "pediatric concerns related to integration, planning, preparedness, and coordination of emergency medical services for infants, children, and adolescents."145 Given the potential of these projects to advance regional systems of care for children, the Commission recommends that Congress appropriate funds for this initiative.

While regional pediatric systems of care rely on the participation of the Nation's 250
children's hospitals,146 other hospitals also must be prepared to provide appropriate care for
children. As noted in the Commission's Interim Report, up to 50 percent of disaster
survivors will be "walk-ins,"arriving at hospital emergency departments through means
other than EMS.147 However, most hospitals are not adequately prepared to treat critically ill
children. Only 6 percent of hospital emergency departments have inventories of pediatric
equipment and supplies that meet national guidelines.148

To support hospital preparedness regionalization efforts, the Commission recommends that
the HHS Hospital Preparedness Program (HPP) include pediatric surge capacity as a
"Required Funding Capability."149 Furthermore, to increase awareness of funding eligibility for
pediatric initiatives, children should be specifically referenced throughout future HPP grant
guidance, rather than grouped within a subset of "at-risk populations."HPP should highlight
and share pediatric funded activities and best practices with hospitals and eligible health care
systems. HHS reported that several States used program funding to develop pediatric specific
initiatives including regionalized pediatric response, evacuation plans, improved risk
communications, improved training, pediatric stockpiles, and pediatric strike teams.150

Notwithstanding the need for greater Federal support, State health care licensing bodies and
the Joint Commission on Accreditation of Healthcare Organizations must be the primary drivers in promoting health care system regionalization and adoption of standards and emergency preparedness recommendations.151

Congress should establish sufficient funding mechanisms to support restoration and
continuity of for-profit and non-profit health and mental health services to children.

The Executive Branch should recognize and support pediatric health and mental health
care delivery systems as a planning imperative in the development and implementation
of the National Health Security Strategy and National Disaster Recovery Framework.

HHS should create Medicaid and Children's Health Insurance Program incentive
payments for providers in disaster areas.

The American Medical Association should adopt a new code or code modifier to the
Current Procedural Terminology to reflect disaster medical care in order to facilitate
tracking of these services and as a means for enhanced reimbursement from public and
private payers.

Health and mental health care providers face significant challenges in restoring their
operations in a timely manner post-disaster, which hinders the consistent provision of care
to children and families during disaster recovery. Therefore, Federal, State, and local disaster
recovery planning must consider existing resource gaps for the recovery of health and
mental health care practices after disasters. The Robert T. Stafford Disaster Relief and
Emergency Assistance Act ("Stafford Act")152 provides funds for repairs to public or nonprofit
medical facilities. However, approximately 85 percent of pediatric treatment in the United
States occurs in privately-owned medical practices.153 Although the Small Business
Administration makes loans to support rebuilding and provide operating capital for private,
for-profit businesses, many practices affected by major disasters may lack the means to
qualify for or repay such loans since health care practices often experience a decline in
patients and variations in health insurance reimbursements. After Hurricanes Katrina and
Rita, it took nearly two years for many physicians in the New Orleans area to treat a volume
of patients sufficient to sustain their practices.154

The Commission recommends that Congress establish sufficient funding mechanisms to
support restoration and continuity of for-profit and nonprofit health and mental health
services to children following a disaster. The National Health Security Strategy recognizes
the importance of restoring access to health services following a disaster. The Strategy states
that pre-event planning is fundamental to resuming service delivery in areas affected by a
disaster. Such planning should address: behavioral health services for both the affected
community and responders; the provision of medical services throughout the recovery
period; and the rebuilding and restoration of health care delivery mechanisms, including
the health care infrastructure.155

In the Interim Report, the Commission recommended the development of a National Disaster Recovery Strategy which, among several provisions, would include:

Continuous access to the full spectrum of pediatric medical services, including a
medical home,156 pediatric specialty services, and children's hospitals.

Federal disaster assistance grants for all medical facilities damaged or destroyed by a
disaster, such as primary medical, dental, and mental health care practices and clinics.

In addition, the Commission recommends that the National Health Security Strategy and the
National Disaster Recovery Framework and Recovery Support Functions prioritize and
support the continuity and restoration of health and mental health practices in jurisdictions
affected by disasters. In addition, Federal, State, and local recovery planning must involve
primary and mental health care providers at the community level.

The Commission further recommends that the Centers for Medicare & Medicaid Services
create Medicaid and Children's Health Insurance Program (CHIP) incentive payments for
providers in areas impacted by disasters. Following Hurricane Katrina, the Federal
Government provided a 10 percent increase in Medicare reimbursements to physicians in
New Orleans after designating Orleans Parish a health professional shortage area.158 However, pediatricians did not benefit from this assistance since eligible children are
insured under Medicaid, not Medicare.159

Finally, the Commission recommends the creation of a unique code or code modifier to the
Current Procedural Terminology (CPT)160 to report professional services provided in a
declared disaster area to public and private health insurance providers. This would allow the
appropriate documentation and tracking of such services in the aftermath of a disaster.
Insurers may also choose to compensate health care providers with higher insurance
reimbursement for services provided to disaster-affected individuals. The Commission is
currently collaborating with the American Academy of Pediatrics to propose a new CPT code
for "disaster-related care"to the American Medical Association's CPT Editorial Panel in
2010.161

Recommendation 3.6: EPA should engage State and local health officials and nongovernmental
experts to develop and promote national guidance and best practices on
re-occupancy of homes, schools, child care, and other child congregate care facilities in
disaster-impacted areas.

EPA and HHS should expand research on pediatric environmental health risks
associated with disasters.

Children may suffer serious health and wellness consequences after disasters due to environmental exposure to and inhalation of particulate matter containing asbestos, lead,
cement dust, and mold.162 Following 9/11, 52.8 percent of 3,184 children enrolled in the World Trade Center Health Registry displayed a new or worsened respiratory symptom and 5.7 percent received a new diagnosis of asthma.163 More recently, a report by the National Center for Disaster Preparedness on the impact of the 2010 Gulf of Mexico oil spill disaster on children and families estimated that over 40 percent of the population living within 10 miles of the coast had experienced some direct exposure to the oil spill, and that households with children were 1.4 times more likely to report oil spill exposure than households without children.164

The Commission recommends that the Environmental Protection Agency (EPA), in
collaboration with its network of Pediatric Environmental Health Specialty Units (PEHSU)165 and other pediatric experts, develop national guidance and best practices for families,
caregivers, health care providers, and responsible parties to determine when it is safe for
children to re-enter or re-occupy a home, school, child care facility, or other facility affected
by a disaster. EPA should partner with HHS and other Federal agencies to expand existing
guidance with information specific to children, including Planning Guidance for Protection
and Recovery Following Radiological Dispersal Device (RDD) and Improvised Nuclear
Device (IND) Incidents,166 Draft Planning Guidance for Recovery Following Biological
Incidents,167 and The White House Office of Science and Technology Policy's draft Clean-up
Decision-Making Guidance for Chemical Incidents, which is under development by an
interagency working group.

The Commission also recommends additional research to expand the evidence base on
environmental health risks to children associated with disasters. In 1997, EPA and HHS
partnered with other Federal agencies to establish the President's Task Force on
Environmental Health Risks and Safety Risks to Children.168 Among the Task Force's
accomplishments were the development of the National Children's Study, the Federal
Strategy Targeting Lead Paint Hazards, and the Healthy School Environments Assessment
Tool to examine environmental threats to children's health.169 The authority for the Task
Force expired in 2005, and efforts are underway to reestablish the Task Force in 2010. The
Commission recommends that the Task Force prioritize research efforts on environmental
health risks of children associated with disasters.170